ProCure™

FDA UDI

Class I (US FDA UDI)

by Twin Med, LLC

Identity

Trade Name: ProCure™ FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Device Name: Hot Pack- Hot Pack Instant 6"x 9" - 24ea/cs FDA UDI
Model / Reference: PC1301 FDA UDI
Description: Hot Pack- Hot Pack Instant 6"x 9" - 24ea/cs FDA UDI

Identifiers

Catalog Number: PC1301 FDA UDI
Primary DI / UDI-DI: 10840330703618 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Hot/cold therapy pack, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 6 Inch FDA UDI
Length — 9 Inch FDA UDI

Category: Hot/cold therapy pack, single-use

ProCure™ by Twin Med, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Twin Med, LLC

Sources (1)

FDA UDI 6fbb6c77-96ac-43f5-bd0f-492c9fc26fc8 37 fields · synced May 31, 2026